Designing a Successful Imaging-Based Pediatrics Clinical Trial

Children are a protected segment of society and pediatric clinical trials are critical to the development of new treatments for childhood diseases. These two principles put a significant burden on clinical trial conduct, especially when trial procedures include complex medical imaging techniques. The goal of this webinar is to describe and discuss challenges and solutions in designing, collecting and analyzing imaging data in support of clinical trials in children and adolescents in a variety of medical indications. Imaging-based endpoints in support of efficacy and safety are discussed with case examples in musculoskeletal disease and skeletal maturation, oncology and hematology using imaging techniques such as radiography, computed tomography, magnetic resonance imaging and sonography. Operational challenges and corresponding solutions that minimize burden and harm on pediatric trial participants, while obtaining high quality imaging-based data, will be discussed.

Speakers

(Moderator) Thomas Fuerst, Ph.D., Chief Science Officer, Bioclinica

Dr. Thomas Fuerst leads the design and scientific oversight of musculoskeletal clinical trials for Bioclinica. Dr. Fuerst received his Ph.D. in medical physics from the University of Wisconsin at Madison and has more than 25 years of clinical trial experience in musculoskeletal, immunology and inflammation, metabolic disorders, women’s health and rare diseases. Prior to joining Bioclinica, he was a faculty member of the University of California, San Francisco, where he served as Associate Director of the Osteoporosis and Arthritis Research Group (OARG). Dr. Fuerst is also a co-founder of the imaging core lab Synarc, where he served as Scientific Director before its merger with Bioclinica in 2014.

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Souhil Zaim, M.D., VP, Medical and Scientific Affairs, Bioclinica

Dr. Souhil Zaim holds an M.D. degree from the University of Algiers School of Medicine, Algeria and a Radiology specialty certification from the University Pierre et Marie Curie (now Sorbonne University), Paris, France followed by fellowships in body imaging and musculoskeletal imaging. Dr. Zaim served as an Assistant Professor at the University of California, San Francisco and a Director at the Osteoporosis and Arthritis Research Group (OARG). Dr. Zaim has over twenty years of clinical research using imaging, focusing on semiquantitative and quantitative assessment of disease using imaging techniques and scoring systems for several NIH and pharmaceutical industry sponsored studies. Prior to joining Bioclinica in 2017, Dr. Zaim served as Chief Medical Officer at Median Technologies since 2013 and as Director and Vice-President, Radiology Services at Synarc since 2001.

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Kenneth W. Gaither, Ph.D., VP, Medical Imaging, Bioclinica

Dr. Kenneth W. Gaither has global responsibility leading the implementation and oversight of clinical trials for Bioclinica and has more than 20 years of experience in bone densitometry, body composition assessment, vertebral fracture and morphology methods, and structural geometry of bone within international multicenter clinical trials. He has published on these areas in peer-reviewed journals and is a member of the American Society for Bone and Mineral Research, the International Society for Clinical Densitometry and the European Crohn´s and Colitis Organisation. Dr. Gaither received his Ph.D. in systems science with a focus on the utilization of simulation modeling in risk-based systems. He has held director and vice president level positions within project management, data management, site selection and operations in a variety of healthcare industries including clinical research organizations, centralized imaging laboratories, and medical device manufacturers.

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